The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current regulatory framework for pharmaceutical manufacturing in a new discussion paper.   The paper, which was jointly released by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on 1 March accompanies the agency’s release of the International Co...

Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...

In this article, the authors discuss how recent advances in AI can be applied to support and augment various regulatory intelligence functions, including knowledge management and precedent research.   Keywords – AI, computer vision, natural language processing, regulatory intelligence   Introduction Regulatory intelligence (RI) involves analyzing large amounts of regulatory information. Much of this research is done manually and requires repetitive and ti...

This article outlines the standardization work on artificial intelligence (AI) being carried out in the joint International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) committee, ISO/IEC JTC 1/SC 42. 1 The SC 42 committee develops international standards that cover both technology capability and nontechnical requirements, such as business, regulatory and policy requirements, and application domain needs, as well as ethical an...

For most of regulatory science’s established history, regulations governing drug safety and efficacy were established on a country-by-country basis. For instance, a US-centric framework was appropriate when most US-manufactured drugs were distributed and sold largely on the US market. Today, the pharmaceutical industry’s expanding global reach means drug distribution is multinational, yet the current regulatory frameworks still are largely national or regional in focus. Th...

In its simplest form, strategy can be considered bringing a new product to market, but it touches every product development lifecycle aspect and can ensure market sustainability. A limited or inadequate strategy can challenge global expansion, thus emphasizing the importance of a well-designed and executed regulatory strategy. This article identifies the requirements for developing a strategy for a drug development plan, as well as postmarketing strategy, with some global ...

The five process groups of a process-based approach to project management are: Initiate, Plan, Execute, Monitor and Control, and Close, according to PMBOK. This article presents opportunities for using a project management framework when strategizing for CMC regulatory submission projects. The authors discuss PMBOK nomenclature, project performance domains, project constraints, process groups, examples of scenarios that may be encountered during a submission project, and t...

This article provides some best practices to align regulatory documents with strategic goals, allowing regulators to understand what a sponsor is trying to achieve, why this goal is important, and how the totality of available information supports the desired regulatory action. Adopting the perspective of a regulatory agency audience, using clear structure and language, and leading teams skillfully are key elements of successful regulatory medical writing.   Keywords ...

An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...

Euro Convergence, RAPS’ annual gathering of medical device, in vitro diagnostic (IVD) and pharmaceutical regulatory professionals, returned in person to Amsterdam on 11-13 May 2022 . More than 500 participants, including 120 industry expert speakers from more than 30 health authorities and notified bodies, made it an event to remember in Amsterdam after two years of virtual conferences. Delegates submitted a record-breaking 20 posters for Euro Convergence 2022. Raque...

This article gives a personal reflection on the development of ICH since its inception in 1990 and during which time the author was involved both as a regulator and, more recently, an industry participant. The evolution of ICH is discussed as it has moved from an international organization involving three regions to a truly global body. The successes and the challenges are discussed, and consideration is given to future development.   Keywords – international harmo...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...